Friday, April 17, 2015

Topic 35: Trends in Data Sciences for Medical Affairs

Data has always been the backbone of medical affairs.Understanding the data that underlies the
company’s products and the products of the competition and understanding the prevalence
and treatment data available about the disease state has always been a
requirement.And, being able to
summarize and explain the meaning of the data is one of the greatest values
that MA brings to the organization.

But as a generator of data analysis and manager of data,
most MA organizations have been passengers not drivers.Most data sets are being generated by
clinical development and analyzed by statistical staff within the clinical
function.Even after the product is on
the market and the data generation turns from a clinical responsibility to a
medical responsibility, most MA organizations still rely on these resources or
the resources of outsourcers to define, manage and analyze their data.

However, as MA groups grow more sophisticated in their use of
data, and as real world data sets available for analysis continue to increase
in size and importance, it may become in the best interest of MA to begin
developing some data science capability of their own.

MA Stats

Some MA organization already have their own stats staff or
stats staff assigned to them but working in clinical, but in my experience this
is still the exception not the rule.Instead, most organization rely on stats people internally who are not
primarily focused on MA or on outsourced stats resources.There are a number of challenges with this
environment. First, for the internally
loaned people, most of them are not that familiar with what MA does and they
are also usually not familiar with using real world data sets.Leveraging them requires bringing them up the
learning curve, sometimes at the expense of time and effectiveness of the
analysis.

Relying on to a large degree on outside statistical help is
also very problematic.In these
outsourcing situations, the cost can be high and the learning curve that you
are paying for becomes the property of the outsourcer to resell to your
competition.Additionally, when a
non-stats person hires and manages a stats outsourcer, it is very difficult for
them to understand if they are getting the best thinking out of the outsourcer
and suggest other alternate directions if they feel the outsourcer is taking a
less than optimal path.It is this very
difficulty that led many clinical organizations, even virtual clinical
organizations, to realize that they always needed some stats capability
in-house, even if it was simply to manage the outsourcers.Finally, working with outsourcers makes it
very difficult to answer quick, smaller “what if” questions that always seem to
come up after the main analysis is complete.

Given the importance of these analysis for MA and the need
to be flexible, I believe that more and more MA organizations will realize that
they need their own stats capability on the MA team – focused full time on the
data sets and analyses that are most relevant to the post-marketing world.

MA Data Managers

While some MA organizations already have stats, I have yet
to see one that has their own data management function.Nevertheless, I am going to suggest that this
will be less rare in the future.Data
managers are responsible for the “care and feeding” of the databases that the
stats team analyzes.A common function
on clinical.

As medical affairs becomes more data sophisticated and as
cutting edge groups decide to build huge repositories of real world data to
perform ongoing analysis, the need for professional MA focused data managers
will grow.These data managers will be
more focused on the collating and cleaning of external data then their clinical
counterparts and that is why I think the need for an MA specialist group will
take hold.